Ministry of Health

Ministry of Health of Uganda

Regulatory Authority

National Drug Authority (NDA)

Medical Device Regulation

1. Ministerial decree ADM.140/323/01 of 20th July 2020

Official Language

English, Swahili

Classification

Class A, B, C, D

Medical Device Registration in Uganda

• Determine the medical device classification
• Appoint your Authorised Representative in Uganda
• Registration can be via:

Track 1 – for products approved in IMDRF countries

Track 2 – for products prequalified by WHO

Track 3 – for products with no prior approval

• The registration will be done via NDAMIS portal
• Once approved, the device can be marketed in Uganda

Documents Required

• Accurately detail application letter (Hard and soft copy)
• Bank deposit slip (prove of payment)
• Sample of the product (if applicable)
• Documentation/Dossier
• Prior market history and approvals

Post-market Requirements

Adverse Event Reporting

Authorized Representative

Yes

License Validity

5 years